While it is ultimately up to patients to make important medical decisions in most cases, those decisions are often based on the information and advice provided by physicians and other medical providers. It’s for that reason that doctors consider everything from the medical history of the individual patient to leading research and recommendations on available treatment options before making their own judgments on a case. The reluctance of some prominent groups and figures within the medical community to accept the warnings of the FDA regarding the use of a common medical tool may result in serious medical malpractice claims if the concerns of the FDA prove to be correct.
In response to their clients’ concerns on how to proceed now that the FDA has recommended that physicians stop using power laparoscopic morcellators to treat some tumors, several major medical malpractice insurance providers are insisting that physicians and medical facilities always receive informed consent from patients before using the device. The FDA claims that the morcellator device can cause the spread of undiagnosed uterine sarcoma in approximately 1 out of every 350 patients treated for fibroid tumors.
Despite the warnings of the FDA, some medical providers and leading organizations contend that the risks associated with subjecting patients to more invasive treatment options are more severe than the chance of spreading cancer. Others argue that estimates provided by the FDA on incidents of cancer spread by the device in question are exaggerated.
Around 50,000 procedures are performed every year using the device. And while some medical groups have chosen to change their informed-consent guidelines so that they may continue to treat patients using the laparoscopic morcellator, one New York medical hospital system has stopped using the device until further notice.
Source: Wall Street Journal, “FDA Advisory on Surgical Device Divides Doctors,” Jennifer Levitz, Jon Kamp, May 21, 2014